Brain CareNotes App for Alzheimer's Disease Caregiver Burden

(I-CARE-Rural-P Trial)

Overseen By Jordan R Hill, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Richard Holden

Disqualifiers: Care recipient in nursing home, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess feasibility and to estimate efficacy of our app "Brain CareNotes" for dementia caregivers who reside in a rural setting (as defined by RUCA codes 4 through 10). The Brain CareNotes app is designed to reduce informal caregiver burden of those caring for individuals with Alzheimer's disease and related dementias (ADRD) and behavioral and psychological symptoms of dementia (BPSD) of individuals with ADRD. The study will enroll up to 60 rural caregivers of community-dwelling individuals living with ADRD. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for six months, with usage reminders.

Who Is on the Research Team?

Jordan R Hill, PhD

Principal Investigator

Indiana University, Bloomington

Richard J Holden, PhD

Principal Investigator

Indiana University, Bloomington

Are You a Good Fit for This Trial?

This trial is for caregivers living in rural areas who are taking care of someone with Alzheimer's or related dementias. They must be able to use an app and commit to the study for six months. Specific details about eligibility criteria were not provided, so it's unclear who can't participate.

Inclusion Criteria

English literate

I am the main caregiver, without pay, for someone with Alzheimer's or dementia living in a rural area.

I am 18 years old or older.

Exclusion Criteria

Care recipient is a permanent resident of an extended care facility (nursing home)

Involvement in another clinical trial that would prevent or interfere with study objectives

Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Brain CareNotes app or an attention control education-only app for six months

24 weeks

Regular app usage with reminders

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain CareNotes

Trial Overview The study tests 'Brain CareNotes,' an app designed to help reduce the burden on informal caregivers of individuals with dementia. Participants will either use this app or a control education-only app over six months, with reminders to encourage usage.

How Is the Trial Designed?

Group I: Brain CareNotes App Experimental Treatment 1 Intervention

The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.

Group II: Attention Control App Active Control 1 Intervention

Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."

Who Is Running the Clinical Trial?

Richard Holden

Lead Sponsor